Citizen Petitions

News & Analysis as of

The US Biosimilars Pathway: Key Questions

In 2015, FDA issued a number of final guidance documents for biosimilars. But many fundamental questions remain unsettled and the industry awaits FDA’s guidance on labeling of biosimilars, the requirements for...more

AbbVie Submits Citizen Petition on Interchangeable Biosimilars

AbbVie, Inc., a biopharmaceutical company, has submitted a citizen petition to the FDA regarding determinations of interchangeability under the BPCIA. An interchangeable biological product is biosimilar to a reference...more

The Ghost of Bendectin – Exorcized by the FDA?

Not quite two years ago, we posted about how, under Wyeth v. Levine, 555 U.S. 555 (2009), and subsequent Supreme Court cases, private plaintiffs can’t make claims that so-and-so should have warned about such-and-such with...more

Putting A Lotion Claim In The Primary Jurisdiction Basket

When Jame Gumb urged his captive to put lotion on her skin, he was not concerned with improving its firmness. While Buffalo Bill from "Silence of the Lambs" may not be who most would think about when reading Franz v....more

Social media campaign ends in disbarment for lawyer

Lawyers using social media: beware! The Louisiana Supreme Court has disbarred a lawyer for launching a “viral campaign to influence and intimidate” judges who presided over her friend’s child custody dispute. In...more

The Name Game: AbbVie’s Citizen Petition Regarding Biosimilar Labeling

On June 2, 2015, AbbVie submitted a citizen petition to the FDA arguing against its interim labeling requirements for biosimilar products under the Biologics Price Competition and Innovation Act (“BPCIA”). As of now, the FDA...more

FDA Denies Amgen’s Citizen’s Petition Awaiting Guidance from the Courts

As we have discussed before, the first generation of biosimilar litigation under the Biologics Price Control and Innovation Act (BPCIA) addresses whether the BPCIA’s patent dispute resolution procedures – the “patent dance” –...more

FDA Denies Amgen's Citizen Petition Regarding Biosimilar Applicant Requirements

Late last week, the U.S. Food and Drug Agency (FDA) dismissed a citizen petition filed by Amgen, Inc. asking the agency to require that biosimilar applicants provide the reference product sponsor with a copy of their...more

Denied Again: FDA Denies Amgen’s Citizen Petition Requesting Certification of Compliance with BPCIA Patent Dance

As discussed previously in Next Steps in the Dance: Amgen Files Citizen Petition at FDA Requesting Mandatory Compliance with BPCIA Patent Procedures, Amgen Inc. (“Amgen”) filed a Citizen Petition with the FDA requesting that...more

Citizen Petitions Aimed at Delaying Generic Competition Remain a Concern

Despite Congress enacting legislation in 2007 to curb misuse, citizen petitions submitted by pharmaceutical companies to the Food and Drug Administration (FDA) may still provide a mechanism for competitors to delay the...more

Petition Questions Lack Of MTA Regulations

Soon, the Office of Administrative Law will decide whether it will determine the merits of a petition for review of underground regulations allegedly being enforced by the Department of Business Oversight (fka Department of...more

Citizen Petitions To Ban Fracking Continue to Gain Momentum In Colorado

Two petitions were turned in to place before local voters ballot measures to ban fracking. On July 9, 2013, opponents of hydraulic fracturing turned in a petition seeking to ban hydraulic fracturing within the city limits of...more

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